QC Analyst - Microbiology (Temporary, 2nd shift, Sat-Mon, 12pm-12:30am)

Genezen; Lexington (MA); Hybrid; USD 60,000 - 72,000; Full time

Job summary

Genezen in Lexington, MA is seeking a QC Analyst - Microbiology for a temporary, 2nd shift role (Sat-Mon, 12pm-12:30am). The position focuses on routine and non-routine QC sampling and testing of controlled environments and production processes in a GMP laboratory, onsite at our Lexington facility.

Responsibilities include environmental monitoring, bioburden and endotoxin testing, data entry, SOP review, and support for CAPAs and change controls as required.

Qualifications

• Experience with QC testing of in-process and product samples in a GMP lab.
• Ability to perform environmental monitoring including bioburden, endotoxin, and growth promotion tests.
• Ability to write, revise, or review SOPs to meet regulatory requirements.

Responsibilities

• Perform QC testing of in-process and product samples adhering to SOPs.
• Ensure environmental monitoring and microbiology sampling/testing meets regulations.
• Write or review SOPs for quality control operations.

Skills

QC testing

Environmental Monitoring

SOP writing/review

aseptic processing

Job description

QC Analyst - Microbiology (Temporary, 2nd shift, Sat-Mon, 12pm-12:30am)

Lexington, MA

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Manypeople have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

The QC Analyst contractor will be responsible for routine and non-routine QC sampling and testing of controlled environments, critical utility systems, and production processes operating in a GMP laboratory. This position works a 2nd shift 12-hour schedule, Saturday-Monday,12-pm-12:30am, fully on-site schedule with occasional holiday support required.

QC Microbiology is responsible for the Environmental Monitoring (EM) program as well as utility monitoring programs, including Water for Injection (WFI), Pure Steam, Purified Water, Compressed Air and Gas systems. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and interdepartmental policies and standard operating procedures (SOPs).

This position is based at Genezen’s state-of-the-art facility in Lexington, MA. The role supports routine operations of a 7-day production schedule. This may include but is not limited to in-process monitoring and testing activities for utility, intermediates, raw materials and drug product samples. The role also supports quality management systems, including; utility monitoring excursions, non-conformance, deviation investigations, corrective and preventive actions (CAPAs), Out of Specifications (OOS), and change controls, as required.

ESSENTIAL JOB FUNCTIONS

• Perform QC testing of in-process and product samples while adhering to standard operating procedures (SOPs).
• Ensure routine QC Environmental Monitoring and Microbiology sampling/testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications, are performed in compliance with all industry regulations and standards.
• Write, revise, or review SOPs for quality control operations to assure regulatory requirements and industry standards are met.
• Support aseptic processing activities.
• Complete documentation, perform data entry and review in accordance with Good Manufacturing Practices (cGMP) applying ALCOA+
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
• Sampling and testing of critical utility systems including water and gas supplied to manufacturing areas.
• Perform data trending and aid in compilation of trend reports.
• Prepare samples for shipment to contract testing laboratories and review of testing data reports, as required.
• Conduct non-conformance and Out of Specification and laboratory investigations and environmental monitoring excursion investigations
• Troubleshooting equipment and microbiological testing methods.
• Training of other Analysts within the department within scope of knowledge.
• Support internal and cross-functional project related activities as needed.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs.
• Work outside of normal business hours, including nights, weekends and holidays, when necessary.